For LTB Office Use Only: Application Rec'd Approved IRB Rec’d Application Reviewed Application Approved LTB Database OSUCCC LTB SR The Ohio State University 334 Tzagournis MRF 420 W. 12th Avenue Columbus, OH 43210 _____ _____ _____ _____ OSUCCC LEUKEMIA TISSUE BANK SHARED RESOURCE APPLICATION FOR MATERIAL/SERVICES I. DIRECTIONS The OSU Leukemia Tissue Bank (LTB) was established for the procurement of leukemic tissue from patients treated at the OSU James Cancer Hospital. Through the Institutional Review Board (IRB)-approved protocol, 1997C0194, blood, bone marrow, apheresis products and tissue samples may be procured from patients with acute and chronic leukemias, lymphomas and other related diseases. Tissue may also be collected, prospectively, processed and stored at the request of investigators who have obtained IRB and OSUCCC Clinical Trials Office approval. In 2005, with continued growth of the bank, Dr Clara Bloomfield was appointed Co-PI and Director. Individual researchers requesting tissue processing services and or patient materials must, according to the by-laws of the OSU Hospital and the Arthur G. James Cancer Hospital and Research Institute, provide an approved and current IRB protocol number in order for the LTB to collect and/or release patient material. The tissue must be collected so that at no time is patient diagnosis compromised. The following information is necessary to correctly document your request for sample processing services or to obtain research materials. Applications must be submitted with an original signature of the principal investigator. Xerox or electronic copies of applications will not be accepted. A. Patient identity is confidential. Specimens will be coded and assessed a processing fee of: CCC Membership status: Cost/sample for sample processing To be determined by review of protocol and agreed upon processing schema B. Investigators must have appropriate approval to obtain sample-processing services from the OSU LTB. Approval can be obtained from the OSU Institutional Review Board (Human Subjects Committee). A COPY OF YOUR HUMAN SUBJECTS APPROVAL SHOULD BE ATTACHED TO YOUR COMPLETED APPLICATION. An annual human subject’s review is required and must be forwarded to LTB in order to maintain your eligibility to participate in LTB services. If you have questions, please call the OSU IRB at 614-292-9046. C. Forward all application materials to: Ms. Donna Bucci, OSU LTB, Room 326 TMRF, 420 W. 12th Ave. CAMPUS (donna.bucci@osumc.edu) II. INVESTIGATOR DATA Principal Investigator: Title: Phone: Email: Phone: Email: Address: Additional contact: Title: Address: OSUCCC LTB: 2/16/2016 - DB For LTB Office Use Only: Application Rec'd Approved IRB Rec’d Application Reviewed Application Approved LTB Database OSUCCC LTB SR The Ohio State University 334 Tzagournis MRF 420 W. 12th Avenue Columbus, OH 43210 _____ _____ _____ _____ III. FUNDING INFORMATION Applications must include valid (active) department or research chartfield information. Specimens that have been processed will be billed to the designated account number. For tracking purposes please include the billing address or administrative office where the copies of the invoices and associated specimen list can be mailed. Applications will not be activated until this information is provided. OSU Chartfield information ORG FUND ACCOUNT OSURF PROJECT PI LISTED ON THIS PROJECT PROJECT END DATE Billing Address: (if different from the investigator address above): Billing Contact: Billing Address: Phone: Fax: Email: Institution Review Board and OSU Clinical Trials Office verification of study activation OSU IRB approved protocol number: Current approval date: OSU Clinical Trials Office (CTO) protocol number: Activation Date: OSU CTO Contact: VERY IMPORTANT: Please provide a copy of the current IRB approval and clinical protocol documents to the LTB Lab Supervisor. OSUCCC LTB: 2/16/2016 - DB For LTB Office Use Only: Application Rec'd Approved IRB Rec’d Application Reviewed Application Approved LTB Database _____ _____ _____ _____ OSUCCC LTB SR The Ohio State University 334 Tzagournis MRF 420 W. 12th Avenue Columbus, OH 43210 SAMPLE PROCESSING SCHEMA (SEE ATTACHED.) To insure that samples for your research project are processed correctly, please provide a COMPLETE research schema showing the following information: How and when samples will be collected and delivered to the LTB for processing. To insure that the lab is adequately staffed, this must include a notification plan for contacting the lab supervisor: (PLEASE NOTE: Although it will make attempt to do so, the LTB is not staffed around the clock and may not be able to provide services after regular laboratory hours or on Sundays). If samples are to be left at a location for pick up by LTB staff, the responsible Research Nurse or Physician must notify the LTB by phone at 688-4754 with the following information: Study ID, location for sample pick up, time/date when samples will be ready for pick up, caller’s contact info in case any other information is needed by the lab. The LTB is not responsible for samples not properly identified, placed for pick up or for which no notification is received. SAMPLES RECEIVED BY THE OSU-LTB THAT AREN’T IDENTIFIED OR WITHOUT A COMPLETED REQUEST, WILL BE HELD FOR 24 HOURS TO ATTEMPT TO OBTAIN THIS INFORMATION. IF NO FOLLOW UP IN FORMATION IS OBTAINED, THE PATIENT MATERIAL WILL BE DISCARDED. Type of samples to be sent to the LTB for processing: Type of sample processing is required: Sample submission form: We encourage investigators to review SOPs for LTB sample preparation to avoid any error in sample preparation. The LTB may provide custom sample processing. A complete protocol, additional reagents (e.g. special buffer solutions for cell lysates) or materials will be supplied by the investigator. NOTE: It is the investigator’s responsibility to notify LTB if a protocol changes. Protocol changes must be submitted in writing 10 working days prior to the date the protocol change will go into effect. OSUCCC LTB: 2/16/2016 - DB For LTB Office Use Only: Application Rec'd Approved IRB Rec’d Application Reviewed Application Approved LTB Database OSUCCC LTB SR The Ohio State University 334 Tzagournis MRF 420 W. 12th Avenue Columbus, OH 43210 _____ _____ _____ _____ AGREEMENT The investigator hereby agrees that processing and procurement service provided by OSUCCC Leukemia Tissue Bank (LTB) Shared Resource will be used only for the research purposes specified in this application and will not be shared with any other investigator without first obtaining permission of the OSUCCC LTB. We understand that while the OSUCCC LTB attempts to avoid supplying tissues contaminated with highly infectious agents such as hepatitis and HIV, all tissues should be handled using universal precautions. The investigator acknowledges that he/she is aware of and follows OSHA regulations for handling human specimens and will instruct their staff to abide by those rules. The investigator further agrees to assume all responsibility for informing and training personnel in the dangers and procedures for safe handling of human tissues. Services are to the research community without warranty of merchantability or fitness for a particular purpose or any other warranty, express or implied. LTB accepts no responsibility for any injury (including death), damages or loss that may arise either directly or indirectly from their use. The investigator hereby agrees to acknowledge the contributions of the OSU Leukemia Tissue Bank (LTB) in all publications resulting from the use of these materials. Recommended wording to the methods or acknowledgment section is as follows: Sample processing and procurement services were provided by the Leukemia Tissue Bank Shared Resource at The Ohio State University Comprehensive Cancer Center, Columbus, Ohio. This service is funded by the National Cancer Institute Grant Number: P30 CA016058 FOR STATE INSTITUTIONS: The recipient institution agrees to be responsible for any claims, costs, damages, or expenses resulting from any injury (including death), damage or loss that may arise solely from the receipt, handling, storage and use of tissues received from TP to the extent permitted under the laws of this State. The undersigned warrant that they have authority to execute this agreement on behalf of the recipient institution. FOR U.S. GOVERNMENT AGENCIES: On behalf of the United States Government, we assume all risks and responsibilities in connection with the receipt, handling, storage and use of tissues received from TP. The United States assumes liability for any claims, damages, injury or expense arising from the use of the material or any derivative, but only to the extent provided under the Federal Tort Claims Act (28 U.S.C. Chapter 171). FOR ALL OTHER INSTITUTIONS: The recipient institution agrees to assume all risks and responsibility in connection with the receipt, handling, storage and use of tissues. It further agrees to indemnify and hold harmless the LTB and the United States Government from any claims, costs, damages or expenses resulting from the use of the tissues provided by the LTB. The undersigned warrant that they have authority to execute this agreement on behalf of the investigator’s institution. BY MY SIGNATURE I AGREE TO THE TERMS SET FORTH IN THE ABOVE AGREEMENT Printed Name of Principal Investigator: Signature of Principal Investigator: Date: UPON RECEIPT OF THIS SIGNED APPLICATION THE LTB SHARED RESOURCE WILL CONSIDER THIS REQUEST. Specific questions about your application should be directed to the OSU LTB 614292-5888. OSUCCC LTB: 2/16/2016 - DB